GYMR A4 Study Long Form Film

Transcription

1 VIDEO INTRO GRAPHICS GRAPHIC DR. SPERLING AUDIO 0:00 [Music & Graphics Only] 0:05 The A4 Study is a landmark clinical trial to prevent the memory loss associated with Alzheimer s disease. 0:10 Thank you for your interest in learning more about the A4 Study. We think this is an incredible opportunity to try to prevent the memory decline associated with Alzheimer's disease. And we're very excited to tell you more about this groundbreaking study. 0:26 Unfortunately everybody over the age of 65 is at increased risk of developing Alzheimer's disease. 0:34 The longer you live, the more likely you are to develop Alzheimer's disease. Research has also shown that having a family history of Alzheimer's disease increases the lifetime risk of developing Alzheimer's disease dementia, particularly a first degree relative. 0:48 There are several factors that may put you at higher risk for Alzheimer s disease, including advanced age and family history. People at higher risk include women and African Americans, Hispanics and Latinos, as well as older individuals of all backgrounds with evidence of elevated amyloid plaque buildup in their brains. Alzheimer s Disease Risk Factors: Age Family history/genes People with Higher Risk to Develop Alzheimer s: Women African Americans Hispanics/Latinos People with an elevated amount of the amyloid protein or elevated amyloid plaque in their brain. DR. SPERLING 1:11 The A4 study is the first study that really tries to identify older individuals who are at risk for Alzheimer's disease on the basis of showing evidence of amyloid plaque buildup in their DB Productions A division of DeSantis Breindel GMYR A4 Study FINAL v2 May 11,

2 brains, by trying to treat them before they have symptoms. We re looking for people who really are still normal, who are living at home and functioning normally. They don t have to have a perfect memory however all of our memories change as we get older, and we re certainly looking for people who are a little bit worried about their memory. 1:43 Scientists believe that the accumulation of amyloid in the brain may play a key role in the memory loss associated with Alzheimer s Disease. The investigational drug being tested in the A4 Study targets the amyloid in the brain with the aim of slowing memory loss. Scientists believe that amyloid accumulation my play a key role in the memory loss associated with Alzheimer s. and Neuron Animation The investigational drug tested in the A4 Study targets amyloid in the brain with the aim of slowing that memory loss. 2:02 Amyloid protein is a protein that accumulates outside, between the brain cells, if you will, and is associated with neuron death. We're now able to visualize amyloid protein in a living person using what's called a PET scan. 2:19 And so we've set up a step by step process so that an interested potential participant can learn about what is amyloid, how do we measure it, how do we interpret the amyloid imaging scans and what we know and what we don't know. 2:39 There are a number of steps involved in the A4 study, including 5 screening visits. At the first visit, we will explain the study and perform a series of basic tests. GRAPHIC: Visit I A4 Study explained and basic screening Medical history Cognitive tests Physical exam ECG DB Productions A division of DeSantis Breindel GMYR A4 Study FINAL v2 May 11,

3 Blood work 2:51 The first step is a very rigorous screening. There are five screening visits during which time we want to make sure that individuals are medically and emotionally fit for participation in the trial and meet all of our criteria. 3:14 We are looking for women and men like you, between the ages of 65 and 85, who have generally normal thinking and memory abilities. You might be a little bit worried about your own memory, which is OK for this study, and you need to have a study partner who can answer questions about how you are doing. We really need older individuals like you who are willing and able to participate in the A4 Study for approximately 3 ½ years. Eligible A4 Participants: Are between the ages of 65 to 85 Have normal thinking and memory abilities Have a study partner (someone with weekly contact, available to answer questions once a year) Are willing and able to participate in the study for approximately 3 ½ years 3:42 The first thing that we will do when you come in for your screening is to make sure that your memory and other cognitive functions are at a level that's normal for your age, your level of education. 3:54 GRAPHIC: Visit 2 PET scan to determine whether there is elevated amyloid, a known AD risk factor 3:54 Then we will have you undergo a PET imaging scan. This is a picture, not of your brain, but actually of the amyloid in your brain. You will lie in a PET scanning machine, where the machine actually tells us how much amyloid is in the brain. DB Productions A division of DeSantis Breindel GMYR A4 Study FINAL v2 May 11,

4 4:18 The PET scan has two possible results. One can either have a result that shows what we call an elevated amyloid level, or a not elevated amyloid level. PET Amyloid Imaging Graphics An elevated amyloid level means that based on the criteria for reading the scan, the person has an accumulation of amyloid that makes them eligible to receive the investigational drug. GRAPHIC with VO 4:38 It doesn't mean you have Alzheimer's disease dementia. It does put you in a group of people who more likely over time to develop cognitive changes that could lead to Alzheimer's disease dementia. In fact one of the goals of the study is to better understand that risk. 4:57 On your third visit, we will review your PET scan results together, and talk about your amyloid status. Visit 3 Review PET scan results for disclosure of amyloid status 5:05 During the 4 th visit, we will perform an MRI, which helps us look at your brain by using a large magnet. Visit 4 MRI Scan 5:12 On visit five, we will talk about the option of participating in a sub-study. Visit 5 Optional Sub-study 5:17 And on your 6 th visit, we will begin treatment, either with the investigational drug or with a placebo. Visit 6 Randomized treatment phase begins Participants receive either the investigational drug or placebo once every 4 weeks via IV DB Productions A division of DeSantis Breindel GMYR A4 Study FINAL v2 May 11,

5 5:26 You will then be scheduled to make monthly visits to the center in order to get infusions. And these infusions require putting a line into your arm; it's an IV. And you'll be sitting comfortably in a chair and the drug or placebo is infused over a period of a half hour. 5:51 In the course of the A4 study an individual can receive the active substance that we are testing, or they may receive a placebo. 6:00 We need to compare whether the investigational drug is working or whether an individual might get better because they've taken the tests many times or because they feel they're doing something and their mood is improved. 6:16 The study is planned to last about three and a half years. And you should plan to make monthly visits for the infusions after the initial screening, which will take about five visits. OUTRO GRAPHICS 6:28 [Music & Graphics Only] Total Running Time 6:54 DB Productions A division of DeSantis Breindel GMYR A4 Study FINAL v2 May 11,

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